| Model Number: | LYFCM |
| MOQ: | 1 unit |
| Price: | 5,000-50,000 USD/unit |
| Delivery Time: | 60-120 days |
| Payment Terms: | T/T |
GMP-compliant sterile lyophilized powder filling and stoppering machine. Features anti-caking micro-dosing technology, achieving speeds up to 5,000 vials/hour with ±0.5% accuracy for bioSteriles and cosmetics.
High-Speed Sterile Dosing for BioSteriles | Up to 5,000 Vials/Hour
Revolutionize your sterile powder production with Lingyao’s Lyophilized Powder Filling Machine, specifically engineered for the stringent demands of the bioSterile, clinical research, and medical cosmetic industries.
Delivering unparalleled dosing accuracy of ≤ ±0.5% at speeds up to 5,000 vials per hour, this system is designed for highly sensitive, hygroscopic materials such as vaccine lyophilizates, mRNA formulations, and premium freeze-dried skincare serums. With an advanced nitrogen-purged environment and integrated stoppering mechanism, it guarantees zero moisture ingress and strict GMP compliance.
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Micro-Dosing / Servo Auger System: Replaces traditional liquid pumps with highly precise servo-driven auger or vacuum micro-dosing mechanisms, ensuring precise milligram-level powder distribution.
Vibration-Free Dispensing: Specifically designed to prevent powder clumping and protect the delicate molecular structure of hygroscopic lyophilized products like collagen peptides.
ISO Class 5 Environment: Seamlessly integrates with Laminar Airflow (LAF) hoods, continuously sweeping the filling zone with HEPA-filtered air to reduce cross-contamination risks by 99.97%.
Nitrogen Purging: Automated pre- and post-filling nitrogen flushing drastically reduces residual oxygen levels inside the vial, extending the shelf life of sensitive biological products.
Servo-Driven Stoppering: Automatically inserts rubber stoppers (half or full insertion) immediately after powder filling, securing the sterile environment before final capping.
Smart HMI Diagnostics: Real-time monitoring of fill weight and environmental metrics via a user-friendly / PLC interface.
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| Specification | Technical Parameters |
| Target Application | Lyophilized Powders, Sterile Antibiotics, Cosmetic Powders |
| Applicable Vial Sizes | 2ml - 100ml Tubular or Molded Glass Vials |
| Production Speed | Up to 5,000 Vials/Hour (approx. 80 BPM) |
| Powder Dosing System | Servo-Driven Auger Filler / Vacuum Micro-Dosing |
| Filling Accuracy | ≤ ±0.5% (Depending on powder flowability) |
| Sealing Mechanism | Automated Rubber Stoppering (with vacuum/nitrogen options) |
| Control System | Advanced PLC with CFR 21 Part 11 Compliant HMI |
| Material Construction | AISI 316L (Contact parts) / AISI 304 (Frame) |
| Air Supply Requirement | 0.4 - 0.8 MPa, Clean Dry Air (CDA) |
| Compliance Standards | cGMP, FDA, CE, ISO Class 5 Compatible |
BioSteriles: Antibiotic powder vials, mRNA vaccine packaging, and monoclonal antibody formulations.
Medical Cosmetics: Vitamin C freeze-dried powders, stem cell treatments, and anti-aging lyophilized serums.
Clinical Research: Scalable from R&D small-batch trials to full commercial manufacturing.
At Lingyao, we understand that seamlessly clearing customs and maintaining peak performance in diverse climates are just as critical as the machine's precision. Our Lyophilized Powder Filling lines are specifically optimized for the regulatory and environmental demands of the MENA (Middle East & North Africa) and Sub-Saharan African markets.
Saudi Arabia (SASO & SABER Ready): Our equipment strictly adheres to SASO (Saudi Standards, Metrology and Quality Organization) technical regulations. We provide all necessary technical dossiers, test reports, and factory audit documentation to facilitate frictionless SABER platform registration, ensuring fast-track customs clearance for Saudi Sterile manufacturers.
African Market Pre-Shipment Certifications: We have extensive experience exporting to diverse African regions. Our machines are built to meet the rigorous PVoC (Pre-Export Verification of Conformity) standards required by Kenya, Tanzania, and Uganda, as well as SONCAP compliance for the Nigerian market.
Tropicalized Engineering for Extreme Climates: To guarantee stable continuous operation in high-temperature and high-humidity environments typical of the African continent and Middle Eastern deserts, the system features Tropicalized Engineering:
Upgraded heat-resistant servo motors and robust ventilation.
IP65/IP67 rated dust-proof and moisture-resistant electrical enclosures.
Anti-condensation design for the nitrogen purging and stoppering stations.
Adaptive Power Configuration: Factory-configured to perfectly match your local power grid parameters (e.g., 415V/50Hz for East Africa or 220V/60Hz for Saudi Arabia), eliminating the need for costly and unstable external transformers.